{"entity":{"id":"panitumumab","kind":"drug","name":"Panitumumab","aka":[],"tldr":"Panitumumab is a fully human EGFR antibody, the preferred first-line partner for chemotherapy in left-sided, RAS-normal bowel cancer after the PARADIGM trial.","summary":"Fully human IgG2 anti-EGFR; fewer infusion reactions than cetuximab and no ADCC. PARADIGM (2022) established superiority over bevacizumab in left-sided RAS wild-type disease; PRIME established it with FOLFOX. Partner of sotorasib in KRAS G12C mCRC (CodeBreaK 300, approved 2025). Same RAS-testing requirement and skin toxicity as cetuximab.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Panitumumab","links":[{"label":"FDA label","url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125147s210lbl.pdf"},{"label":"NICE TA439","url":"https://www.nice.org.uk/guidance/ta439"},{"label":"EMA Vectibix","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vectibix"}],"tags":[],"related":["ras-wild-type","kras-g12d"],"cancers":["colorectal"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["egfr"],"drugs":[],"companies":["amgen"],"institutions":[],"pathways":["ras-mapk"],"terms":[],"trials":["paradigm","codebreak-300","nct06252649","nct06820463","nct07659795","nct07172919","prime","cairo5","foxtrot"],"people":[],"bottlenecks":[],"keyPapers":["paper-douillard-prime-panitumumab-ras-nejm-2013","paper-arnold-primary-tumour-side-ras-wild-type-ann-oncol-2017","paper-diaz-molecular-evolution-egfr-resistance-colorectal-nature-2012"],"journals":[],"dependsOn":[],"notes":["Colorectal cancer biomarkers: the PRIME extended RAS analysis moved the label from KRAS exon 2 to all RAS. Among 639 KRAS exon 2 wild-type patients, 108 (17%) had another RAS mutation and did worse on panitumumab-FOLFOX4, while the 512 with no RAS mutation gained 5.8 months of overall survival (26.0 against 20.2, hazard ratio 0.78) (Douillard 2013). Left-sided primary is the second requirement (Arnold 2017)."],"brand":"Vectibix","modality":"Monoclonal antibody (anti-EGFR)","mechanism":"High-affinity EGFR blockade without effector function.","approvals":[{"region":"US","year":2006,"indication":"EGFR-expressing mCRC after chemotherapy (later RAS wild-type)"},{"region":"US","year":2014,"indication":"First-line RAS wild-type mCRC with FOLFOX"},{"region":"US","year":2025,"indication":"KRAS G12C mCRC with sotorasib"},{"region":"EU","year":2007,"indication":"Metastatic colorectal cancer; RAS wild-type from 2013","note":"Vectibix marketing authorisation issued 3 December 2007."},{"region":"England (NICE)","year":2017,"indication":"Previously untreated RAS wild-type metastatic colorectal cancer with FOLFOX or FOLFIRI","note":"TA439 recommends panitumumab within its marketing authorisation subject to the patient access scheme."}],"mechanismSteps":["Panitumumab binds EGFR on the tumour cell surface","Blocks ligand-driven activation of the receptor","Downstream RAS-MAPK signalling falls in RAS wild-type cells","Cells stop proliferating; in RAS-mutant cells the pathway stays on and the drug does nothing"],"dosing":{"route":"Intravenous","schedule":"6 mg/kg every 2 weeks","modifications":"Withhold for grade 3-4 dermatologic toxicity","monitoring":"Electrolytes; skin","source":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125147s210lbl.pdf"},"toxicity":[{"event":"Dermatologic toxicity (rash, paronychia)","note":"Very common; boxed warning"},{"event":"Hypomagnesaemia"},{"event":"Diarrhoea"}],"access":[],"regulatoryEvents":[{"date":"2006-09","type":"approval","region":"US","note":"Accelerated approval, refractory mCRC"},{"date":"2006-09-27","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"EGFR-expressing metastatic colorectal carcinoma with progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens"},{"date":"2014-05","type":"label-change","region":"US","note":"First-line with FOLFOX in RAS wild-type (PRIME)"},{"date":"2014-05-23","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2006 converted to traditional approval 7.7 years after it was granted.","indication":"EGFR-expressing metastatic colorectal carcinoma with progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens"},{"date":"2025-01","type":"approval","region":"US","note":"With sotorasib for KRAS G12C mCRC (CodeBreaK 300)"}]},"route":"/drugs/panitumumab/","neighbours":{"biomarker":[{"id":"kras-g12c","kind":"biomarker","name":"KRAS G12C","route":"/biomarkers/kras-g12c/"},{"id":"kras-g12d","kind":"biomarker","name":"KRAS G12D (and other non-G12C KRAS mutations)","route":"/biomarkers/kras-g12d/"},{"id":"ras-wild-type","kind":"biomarker","name":"RAS wild-type (extended KRAS and NRAS testing)","route":"/biomarkers/ras-wild-type/"}],"cancer":[{"id":"colon-cancer","kind":"cancer","name":"Colon cancer (adenocarcinoma of the colon)","route":"/cancers/colon-cancer/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"kras-g12c-colorectal","kind":"cancer","name":"KRAS G12C-mutant colorectal cancer","route":"/cancers/kras-g12c-colorectal/"},{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"company":[{"id":"amgen","kind":"company","name":"Amgen","route":"/companies/amgen/"}],"pathway":[{"id":"colorectal-cancer-signalling","kind":"pathway","name":"Colorectal cancer (KEGG map)","route":"/pathways/colorectal-cancer-signalling/"},{"id":"ras-mapk","kind":"pathway","name":"RAS / RAF / MEK / ERK (MAPK)","route":"/pathways/ras-mapk/"},{"id":"rtk-activation","kind":"pathway","name":"Receptor tyrosine kinase activation","route":"/pathways/rtk-activation/"}],"trial":[{"id":"nct07659795","kind":"trial","name":"A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer","route":"/trials/nct07659795/"},{"id":"nct07172919","kind":"trial","name":"A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation","route":"/trials/nct07172919/"},{"id":"nct06820463","kind":"trial","name":"A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil,","route":"/trials/nct06820463/"},{"id":"cairo5","kind":"trial","name":"CAIRO5","route":"/trials/cairo5/"},{"id":"chronos","kind":"trial","name":"CHRONOS","route":"/trials/chronos/"},{"id":"codebreak-300","kind":"trial","name":"CodeBreaK 300","route":"/trials/codebreak-300/"},{"id":"foxtrot","kind":"trial","name":"FOxTROT","route":"/trials/foxtrot/"},{"id":"nct06509126","kind":"trial","name":"Intermittent or Continuous Panitumumab Plus FOLFIRI for Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer","route":"/trials/nct06509126/"},{"id":"nct03384238","kind":"trial","name":"Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery","route":"/trials/nct03384238/"},{"id":"paradigm","kind":"trial","name":"PARADIGM","route":"/trials/paradigm/"},{"id":"nct05786924","kind":"trial","name":"Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies","route":"/trials/nct05786924/"},{"id":"nct05845450","kind":"trial","name":"Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)","route":"/trials/nct05845450/"},{"id":"prime","kind":"trial","name":"PRIME","route":"/trials/prime/"},{"id":"nct06245356","kind":"trial","name":"Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer","route":"/trials/nct06245356/"},{"id":"nct06252649","kind":"trial","name":"Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal","route":"/trials/nct06252649/"},{"id":"nct03635021","kind":"trial","name":"Study to Evaluate the Efficacy of FOLFOX + Panitumumab Followed by FOLFIRI + Bevacizumab (Sequence 1) Versus FOLFOX + Bevacizumab Followed by FOLFIRI + Panitumu","route":"/trials/nct03635021/"},{"id":"nct06998940","kind":"trial","name":"Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations","route":"/trials/nct06998940/"},{"id":"nct02885753","kind":"trial","name":"Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal C","route":"/trials/nct02885753/"},{"id":"nct05863195","kind":"trial","name":"Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial","route":"/trials/nct05863195/"},{"id":"nct06490536","kind":"trial","name":"The Sagittarius Trial","route":"/trials/nct06490536/"},{"id":"nct06714357","kind":"trial","name":"ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent/Revert Resistance in Colorectal Cancer","route":"/trials/nct06714357/"}],"paper":[{"id":"paper-codebreak-300-nejm-2023","kind":"paper","name":"CodeBreaK 300: sotorasib plus panitumumab in chemotherapy-refractory KRAS G12C colorectal cancer","route":"/key-papers/paper-codebreak-300-nejm-2023/"},{"id":"paper-misale-kras-acquired-resistance-anti-egfr-colorectal-nature-2012","kind":"paper","name":"Emergence of KRAS mutations and acquired resistance to anti-EGFR therapy in colorectal cancer","route":"/key-papers/paper-misale-kras-acquired-resistance-anti-egfr-colorectal-nature-2012/"},{"id":"paper-douillard-prime-panitumumab-ras-nejm-2013","kind":"paper","name":"Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer (PRIME)","route":"/key-papers/paper-douillard-prime-panitumumab-ras-nejm-2013/"},{"id":"paper-foxtrot-preoperative-chemotherapy-colon-jco-2023","kind":"paper","name":"Preoperative chemotherapy for operable colon cancer: mature results of an international randomized controlled trial (FOxTROT)","route":"/key-papers/paper-foxtrot-preoperative-chemotherapy-colon-jco-2023/"},{"id":"paper-arnold-primary-tumour-side-ras-wild-type-ann-oncol-2017","kind":"paper","name":"Prognostic and predictive value of primary tumour side in patients with RAS wild-type metastatic colorectal cancer treated with chemotherapy and EGFR directed antibodies in six randomized trials","route":"/key-papers/paper-arnold-primary-tumour-side-ras-wild-type-ann-oncol-2017/"},{"id":"paper-diaz-molecular-evolution-egfr-resistance-colorectal-nature-2012","kind":"paper","name":"The molecular evolution of acquired resistance to targeted EGFR blockade in colorectal cancers","route":"/key-papers/paper-diaz-molecular-evolution-egfr-resistance-colorectal-nature-2012/"}],"pairing":[{"id":"anti-egfr-left-sided","kind":"pairing","name":"Anti-EGFR antibody + chemotherapy in left-sided RAS/BRAF wild-type mCRC","route":"/pairings/anti-egfr-left-sided/"}],"roadmap":[{"id":"colorectal-roadmap","kind":"roadmap","name":"Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation","route":"/roadmaps/colorectal-roadmap/"}],"term":[{"id":"anti-egfr-rechallenge","kind":"term","name":"Anti-EGFR rechallenge","route":"/terms/anti-egfr-rechallenge/"},{"id":"colorectal-uk-drug-access","kind":"term","name":"Colorectal cancer drugs in England: what NICE has recommended","route":"/terms/colorectal-uk-drug-access/"},{"id":"chemotherapy-side-effects-colorectal","kind":"term","name":"Living with FOLFOX, CAPOX, FOLFIRI and the EGFR antibodies","route":"/terms/chemotherapy-side-effects-colorectal/"}],"person":[{"id":"yoshino-takayuki","kind":"person","name":"Takayuki Yoshino","route":"/people/yoshino-takayuki/"}],"drug":[{"id":"tempus-xt-cdx","kind":"drug","name":"Tempus xT CDx","route":"/drugs/tempus-xt-cdx/"},{"id":"therascreen-cdx","kind":"drug","name":"therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF)","route":"/drugs/therascreen-cdx/"}]}}